Lack of compliance in the taking of recommended medications including the following of therapeutic treatment regimens may lead to serious health consequences for patients and increase the overall cost of care. For example, failure to take a prescribed medication or taking the medication at incorrect times may result in a prolongation or possible accentuation of the disease state. Conversely, over-dosage may result in adverse or non-intended side effects thereby also possibly negatively impacting the health and well being of the patient.
In many instances, the patient or caregiver may not be able to objectively ascertain whether or not a medication has been taken in the appropriate fashion or not. In order to provide an independent assessment of medication delivery and uptake, numerous solutions have been proposed.
For instance, Kell (U.S. Pat. No. 5,652,146) teaches the use of monitoring urine in order to ascertain patient compliance regarding whether or not a medication has been taken or not as well as estimating the dosage of the medication within the patient. However, this form of monitoring still requires compliance on the part of the patient for obtaining the necessary urine sample and requires similar metabolic profiles to be shared amongst individuals in order to enable estimation of drug ingestion and levels.
Alternatively, Katzman (U.S. Pat. No. 6,180,414) teaches the use of breath monitoring for drug metabolites, as compared to urine, to thereby ascertain whether a drug has been ingested or not. However, this approach likewise is dependent on the metabolic profile of the individual which may vary from expected patterns based on disease state, co-morbidities, genetics, lifestyle, etc.
To improve upon the need for metabolic detection and analysis, Melker, et al. (US Patent Application No. 2005/0054942) teaches the use of adjuvant to the drug or agent which then may be detected in the breath as a defined odor. In similar fashion, Kell (U.S. Pat. No. 5,776,783) teaches the addition of markers which may be added to drug formulations and then detected in urine to enable determination of drug ingestion.
To supersede the need for detection of a metabolite and/or absorbed/metabolized marker associated with an ingested drug, others have proposed the use of direct signaling of drug ingestion. In particular, the use of radio transmitters or radiofrequency tags (RF tag) has been proposed by numerous individuals. For example, Covannon, et al. (U.S. Pat. No. 7,616,111) teaches the use of an ingestible RF tag to monitor the consumption of medicines. Likewise, Danowski, et al., (U.S. Pat. No. 7,382,263) teaches the use of a shielded RF tag to monitor the consumption of drugs. In yet another related form, Zdeblick et al., (US Patent Application No. 20080284599) teaches the use of a transmitter which becomes activated upon digestion and exposure to body fluids such as stomach acids, etc.
However, none of the above methods for determining compliance to medicine ingestion considers whether the ingested materials result in a desired physiological outcome or not. What is needed is a system that enables not only determination of compliance to medication use but also gauges the physiological outcomes associated with compliance such that medication may be more properly prescribed (e.g. titrated) and the taking of the medication in a desired fashion verified.